MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW; PUMP, INFUSION, ELASTOMERIC

Model Number	13472
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Onq bupivacaine 0.2% at 10ml/hr due to be empty at 1830.Patient reports onq empty at 0800.Rate regulator set at 10ml/hr checked by patient.Infusion possibly ran in at a faster rate ending sooner than anticipated.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 16067800
• Report Number: 16067800
• Device Sequence Number: 20402108
• Product Code: MEB
• UDI-Device Identifier: 00193494134723
• UDI-Public: 00193494134723
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2022
• Report Date (Section F): 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 13472
• Device Catalogue Number: CB004
• Device Lot Number: 30155153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 12/29/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/29/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/06/2022